Efficacy of Tranexamic Acid in Foot and Ankle Surgeries

Bunion Clinical Trial

Official title:

Efficacy of Tranexamic Acid in Foot and Ankle Surgeries- a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653429
• Other study ID #: GCO 17-1691
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often underestimated. However there has been growing emphasis on identification of these injuries and practice patterns.

Description:

Approximately 20% of all foot and ankle fractures are open. Excellent operative field without measurable bleeding remain prerequisite of most orthopedic procedures. Increase blood loss can increase the risk of infection, hematoma formation and wound complications. Presence of blood in synovium not only has direct corrosive effects but also causes increased intra capsular pressure leading to capsular fibrosis culminating as ankyloses.

Tourniquets are employed to optimize surgical field visualization thereby limiting operative duration and improving technical precision. There are several unwanted effects that can arise from use of tourniquet like neurapraxia, vascular injury, post operative swelling etc. Hence there is a growing interest in achieving the same operative goals without the use of tourniquet.

Antifibrinolytics come to one's rescue to achieve a blood sparing effect. Its efficacy in reducing intra operative and post operative blood loss is well documented in cardiac surgery, hip and knee replacement surgery and spinal surgery. Tranexamic acid is a synthetic antifibrinolytic drug that competitively blocks the lysine-binding sites of plasminogen, plasmin and tissue plasminogen activator, thereby delaying fibrinolysis and blood clot degradation. It has been effectively used as IV, oral, topical as well as intra articular dosing. The effects of IV administration lasts 8-17 hours after the initial dose. Orthopedic surgeons have incorporated TXA into multiple elective surgeries as a means of reducing blood loss and transfusion requirements. Reduced bleeding translates to decreased incidence of wound hematoma and other complications.

Effectiveness of Tranexamic acid(TXA) is unknown in foot and ankle surgeries. The aim of this study is to not only evaluate effectiveness of intravenous TXA in reducing post operative blood loss during foot and ankle surgeries but also if it modulates to reduced wound complications and reduced narcotic consumption.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• ASA (American Society of Anesthesiology) class I-IV

• age 8-75.

Exclusion Criteria:

• ASA class V

• morbid obesity

• patient refusal

• patients with known coagulopathy disorder

• renal insufficiency

• hepatic dysfunction

• serious cardiac disease

• an allergy to TXA or receiving antiplatelet and /or anticoagulant drugs will be excluded.

Related Conditions & MeSH terms

• Bunion
• Foot and Ankle Surgeries

Intervention

Drug:
• Tranexamic Acid
administered prior to surgical incision
• Normal saline
administered prior to surgical incision

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Ichan School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (1)

Xie B, Tian J, Zhou DP. Administration of Tranexamic Acid Reduces Postoperative Blood Loss in Calcaneal Fractures: A Randomized Controlled Trial. J Foot Ankle Surg. 2015 Nov-Dec;54(6):1106-10. doi: 10.1053/j.jfas.2015.07.006. Epub 2015 Aug 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Estimated Blood Loss	Total estimated blood loss in millilitres during the surgery	Average intra operative time 1-2 hours
Secondary	Number of Participants With Wound Complications	Number of participants with wound complications at first post-operative visit and at 2 weeks post surgery	at first post-operative visit, 2 weeks post surgery
Secondary	Intra Operative Narcotic Consumption	Total intraoperative narcotic consumption in terms of morphine equivalents.(mme)	Average intra operative time 1-2 hours
Secondary	Post Operative Narcotic Consumption	Post operative narcotic consumption, morphine mili equivalents	2 weeks after surgery